FDA Tobacco Bill Would Cause Countless Deaths: By Hindering, Not Enhancing Development of Safer Cigarettes, Proposal Would Kill People, Not Save Lives

One of the most common misperceptions about the proposed FDA tobacco legislation is that through its tobacco product standards, it would result in safer cigarettes which would reduce morbidity and mortality and save "countless" lives.

The assumption is that by reducing levels of certain tobacco smoke constituents, the FDA could mandate safer cigarettes.

The Rest of the Story

There are two major problems with this.

1. Modified Risk Tobacco Product Provisions - An End to Safer Cigarettes

First of all, the bill contains language which I feel puts a death knell to harm reduction as a strategy. It prohibits the marketing of any newer, safer cigarette, unless it meets FDA approval. But here's the catch - in order to meet FDA approval, you would have to prove that the product improves health, both on an individual and a population level. To do that, you'd have to conduct epidemiologic studies in which smokers were followed for 10-20 years. And you'd have to hope that they stuck with their products (conventional vs. new), without switching, for the entire period. In short, this is impossible. In my view, this legislation would make it impossible to produce and market safer cigarettes. It essentially takes all the incentive away. No cigarette company is going to want to spend millions of dollars on testing and producing a safer cigarette when they know it is going to be virtually impossible for them to ever market it.

And this is precisely why I think Philip Morris favors this legislation. Philip Morris realizes that the bill sets up an impossible standard for new products. Thus, it ensures that the existing market is basically frozen - obviously, this is a dream come true for the company with the largest current market share, because it stifles competition.

I think the only way to get safer cigarettes would be to allow the free market to produce them - not by creating this elaborate regulatory scheme.

In fact, if you actually read the legislation [see section 901(g)(1)], you'll see that it is not just virtually impossible to meet the standards required to market a reduced risk product, it is actually impossible. In order to prove that a product reduces health risks as it is actually used, both on an individual and population basis, you'd have to demonstrate the results of a study in which the product is marketed the way it would be marketed in real life - that is, as a reduced risk product. But you can't market it as a reduced risk product until you've proven that it reduced risks.

This is truly a catch-22. You cannot market a product as reduced risk until you've proven it reduces risk, but you cannot possibly prove that it reduces risk until you've marketed it as such.

Thus, the proposed legislation not only represents a de facto end to the prospect of truly safer products - it represents an actual death knell for any meaningful harm reduction strategy.

2. Tobacco Product Standards - An Exercise in Lunacy

Although the rhetoric by groups like the Campaign for Tobacco-Free Kids sounds great, the truth is that these standards would not help smokers, in my opinion.

The problem is that we simply do not know which of the constituents in tobacco smoke, and at what quantities, are responsible for what diseases. So the Campaign for Tobacco-Free Kids can talk all they want about how FDA will be able to reduce levels of certain toxins and produce a safer cigarette, but that's a pipe dream. It would take difficult to conduct, long-term epidemiologic studies, where you'd have to follow smokers of conventional vs. new products for 10-20 years, before you could have an answer to this question. But in the mean time, we wouldn't know what the risks are - or even if the risk could be decreased! Essentially, the bill would be using smokers as guinea pigs. Perhaps some would view that as acceptable because the product is dangerous anyway. However, the problem is that smokers are going to naturally assume that these products are safer - and we won't know that is true. I think it would greatly deceive smokers into thinking that the product is safer, when it may well not be any safer at all, and could potentially be more hazardous.

Unfortunately, we simply do not have any idea whether it is even possible to reduce the toxicity of cigarettes by reducing the levels of specified components.

All in all, I think the entire approach is flawed, because if you want safer cigarettes, you need to use the free market approach to set up competition between the companies for a safer product. This legislation does the opposite. It takes away the free market completely and puts all decisions into the hands of FDA. But it gives the FDA a mandate which sets up impossible standards that could never be met for new products. What it really does is ensure that existing products will be institutionalized and protected from competition. This, indeed, is the reason why Philip Morris supports the bill, and all the smaller companies oppose the bill. What the smaller companies despise is the removal of any serious chance to compete in the market - and largely, the market we are talking about is potentially safer products.

Philip Morris wants to freeze the market as is, so that Marlboro - one of the highest risk products imaginable - will be able to dominate the market, without any serious competition from potentially safer products which could advertise themselves as being safer than Marlboro and thus gain market share among the "health-conscious" segment of smokers who are looking to reduce their risks while still satisfying their demand for cigarettes.

If you really think about it, you'll see that the approach of trying to reduce the levels of specific smoke constituents is complete lunacy. When you have no idea which constituents, in what combination, and at what concentrations, cause which diseases that are associated with smoking, then it is impossible to produce a cigarette that you know will be safer simply by mandating a reduction in the levels of various smoke constituents.

The one thing you will never hear the supporters of this legislation do is estimate the number of lives they think this legislation will save. All they can do is talk about "countless" lives being saved. And they are quite correct. The lives are countless. You cannot count them because they do not exist!

It is estimated, for example, that there are over 60 compounds in tobacco smoke which cause cancer. So what sense does it make to require the companies to take out two or three of them? What if they take out the wrong ones? What if the actual compound which causes most of the cancer is not one of those chosen to be removed? What if smokers believe that this is a safer product and start smoking more? This approach could actually kill people, rather than save lives.

And it could also kill people by reducing youths' perceptions of the hazards of cigarette smoking. If youths are led to believe (correctly) that the FDA now regulates every ingredient of the cigarette and that (incorrectly) because of this, countless lives will be saved, does it not make sense for these kids to infer that cigarettes are not as bad as they used to be? We know for a fact that any decline in the perceived harm of cigarettes results in an increase in youth smoking. So I'm quite serious when I opine that the proposed FDA legislation could well kill more people than it saves.

You want an estimate of the number of lives that it will cost? Sure - I'm happy to provide one. In my expert opinion, the FDA legislation will kill .... let's see.... why don't we say countless numbers of people.

New Study Challenges Thinking on Use of NRT During Pregnancy

A new study published in the current issue of the Journal of Health Psychology challenges the conventional wisdom that pregnant smokers should be instructed to use nicotine replacement therapy (NRT) if they are unable or unwilling to quit smoking during pregnancy.

The article highlights the finding that nicotine is probably the agent most responsible for the adverse effects of smoking on the fetus. Nicotine is a neuroteratogen, and "There is now abundant evidence that normal fetal development can be disrupted more specifically by nicotine than by any other component of cigarette smoke. Nicotine, which impacts the brain during critical stages of its intrauterine development in experimental animals, is in the offspring of smoking mothers also the most likely cause of the deficits in learning and memory, and the emotional and behavioral problems seen in childhood and later in life. ... Just published new findings provide experimental evidence that nicotine exposure in pregnancy is responsible for auditory–cognitive deficits in the offspring. ... Prenatal nicotine also primes the adolescent brain for depression, and for nicotine addiction in future years."

Moreover, the article argues that the benefits of NRT use during pregnancy have not been sufficiently demonstrated. Specifically, it is not clear that the benefits of NRT outweigh its risks.

One risk that the article addresses is the possibility that by giving smokers an "easy" alternative, they will not take the issue seriously. If all you need to do is pop a pill and you will lose the urge to smoke, then how compelling is it to describe smoking as being an addictive behavior that requires intense effort to overcome?

Another risk addressed by the article is that because NRT is so unsuccessful during pregnancy, a substantial proportion of pregnant women may continue to both smoke and use NRT, resulting in very high nicotine levels for the developing fetus.

The study concludes: "It is easy not only for the counselors to prescribe NRT, it is also easy for the clients to receive it: they may conveniently assume that this is all that needs to be done, and the urge to smoke may go away in due course. While there is compelling experimental and clinical evidence that nicotine harms the developing fetus in several ways, evidence is lacking that NRT aids smoking cessation in pregnancy. There are pregnant women today who would have quit but are wearing nicotine patches, persuaded by the safety assurances about NRT use. Moreover, new evidence reveals that offering a remedy for a risky behavior inadvertently promotes it by suggesting that the risk is manageable."

The Rest of the Story

I think this is a very important perspective that needs to be considered. Unfortunately, the researchers who are in the greatest positions to influence national policy on treatment of smoking cessation (i.e., those chairing and serving on the panels that are developing the recommendations) are so financially conflicted because of their receipt of pharmaceutical funding that they are in no position to be able to adequately consider such a perspective.

Perhaps now it is easier to see why I have argued that the tobacco control movement is so biased by virtue of its acceptance of money from pharmaceutical companies that we are no position to make rational, balanced, objective policy regarding smoking cessation.

As I pointed out last summer, the World Conference on Tobacco or Health itself was sponsored by Big Pharma, and this precluded the conference from being an objective scientific symposium.

While I have argued previously that these conflicts of interest have harmed tobacco control by denigrating our scientific integrity and objectivity, this article points to the possibility that these financial conflicts of interest are doing more damage than that. Perhaps they are actually harming the public's health because of our promotion of treatments whose costs and risks outweigh their benefits to patients.

Now I don't think there's any doubt that Dr. Fiore needs to be replaced as the chair of the panel which is re-examining the national smoking cessation guidelines put out by the Public Health Service, and that no members should be a part of the panel who have any significant financial conflicts of interest.

You don't appoint a fox to guard a hen house.

Iowa Eyes $1 Per Pack Cigarette Tax Increase to Fund Universal Health Care Coverage

Governor Chet Culver and Democratic leaders in Iowa have proposed a one dollar per pack increase in the state's excise cigarette tax in order to provide the revenues needed to fund universal health care coverage for Iowans. According to an article in the Charles City Press, improving health care coverage was a critical part of the election campaign for the governor and many Democratic leaders. However, this coverage cannot be provided without finding a new source of revenues, and a cigarette tax is being proposed as the source: "We cannot reach universal health care without a large infusion of public dollars,’’ said Sen. Jack Hatch, D-Des Moines."

According to an article in the DesMoines Register, "Gov. Chet Culver has offered "compelling arguments" for a $1-per-pack cigarette tax increase, and lawmakers likely will make a quick decision on the issue, House Speaker Pat Murphy said Friday. Murphy, a Dubuque Democrat, initially resisted Culver's call for the increase in the cigarette tax, arguing that lawmakers likely would not approve more than a 60-cent-a-pack increase. But Murphy said he and many other legislators are softening their opposition because of pressure from Culver and a realization that proposed expansion of health care programs rely on the full $1 increase. ... Murphy said he is working to ensure legislators understand that the cigarette tax is key to Culver's plan to expand access to health care, including to 50,000 children who lack coverage and to 6,000 adults working at or near the poverty level. "One of the things that legislators have to understand is that several of the things Governor Culver sets out in his budget are based on this," Murphy said."

The Rest of the Story

As currently fashioned, this proposal is a very bad idea. The last thing in the world that we want to do is to make health care coverage of our poorest citizens dependent upon people continuing to smoke.

While it may appear attractive as a short-term fix, in the long-run, all this idea does is to make the state of Iowa, and the health of its citizens, dependent upon continued cigarette consumption. It all but eliminates the incentive for policy makers to take any subsequent actions that would substantially reduce cigarette smoking rates in Iowa. This is not a prescription for a healthy public health system or for healthy public health policy.

In fact, the proposal would establish an infrastructure under which healthy public health policy can no longer thrive. You simply cannot have rational public health policy in a state when your children and your poor are depending on cigarette tax revenues in order to be able to obtain their health care.

I have a number of suggestions for opponents of this legislation. Actually, they are ideas for T-shirts that could be used to reveal the true nature of what lawmakers in Iowa are on the verge of establishing. Here goes:

1. "Support our children. Buy by the carton."

2. "Support the poor in Iowa. Smoke cigarettes."

3. "Help provide health care coverage for all Iowans. Chain smoke."

4. "Try harder. Be a better citizen. Help ensure your neighbor's health. Smoke more."

5. "Keep health care available for all Iowans. Smoke early and often."

6. "Don't let 50,000 kids down. They're depending on you. Please don't quit smoking. Do it for the kids."

7. "Help 6,000 poor Iowans get health care. Smoke as much as you can."

The knee-jerk support for any and all cigarette taxation by public health and anti-smoking groups is problematic. This kind of thinking supports the above absurdity. If anti-smoking groups made it clear that they would not support cigarette tax increases unless the revenue was used to directly benefit smokers and reduce tobacco-related morbidity and mortality (i.e., specifically allocated to fund smoking education, prevention, and treatment programs), then we would not likely have this kind of stupidity going on.

Unfortunately, the support of anti-smoking groups for cigarette taxation is a knee-jerk response, with very little thought going into the unintended consequences of these policies. And having health care dependent upon continued smoking is one of the most absurd of these consequences.

Not all cigarette tax increases are win, win, win proposals, as the Campaign for Tobacco-Free Kids and other anti-smoking groups have suggested. When our health care system depends upon continued cigarette consumption in order to provide essential medical care to the children and poor, then we are not in a win situation. In fact, it's about as bad of a loss as I can think of when it comes to funding for health care.

Congressman Waxman Deceives American People in Promoting FDA Tobacco Legislation; Campaign to End Tobacco Industry Deception is Based on Deception

In a statement released yesterday in support of legislation that he is co-sponsoring that would give the Food and Drug Administration (FDA) limited regulatory authority over tobacco products, Congressman Henry Waxman hid from the American people the fact that this legislation is vigorously supported by the nation's largest tobacco company and implied, incorrectly, that Big Tobacco is opposed to the legislation.

Representative Waxman stated: "The days of Congress doing the bidding of the tobacco industry are over. This long overdue legislation would give FDA broad powers to regulate tobacco products and protect public health."

The Rest of the Story

In my view, this is an attempt to pull the wool over the eyes of the American people. The truth is that by enacting the FDA legislation, Congress would be doing the bidding of the largest tobacco company - Philip Morris. Altria (the parent company of Philip Morris) is lobbying vigorously for passage of the legislation, which it has called its chief legislative priority for the current session of Congress.

Telling the public that the days of Congress doing the bidding of the tobacco industry are over implies that Big Tobacco is uniformly opposing the legislation.

But the truth is that Philip Morris - the largest company that makes up Big Tobacco - strongly supports the legislation. So it is disingenuous to tell the American people anything other than that Congress will be doing the bidding of Philip Morris if it enacts this legislation.

If you're not willing to tell the truth, then you are in no position to be introducing legislation to tell the tobacco companies what they can and cannot do. You are in no position to complain about deceptive statements that tobacco companies are making.

Representative Waxman now joins Senator Kennedy and the Campaign for Tobacco-Free Kids in what is, ironically, a campaign of deception that aims to end the deception by tobacco companies.

Regardless of one's position on the proposed legislation, what I would hope we can all agree is that if deception on the part of tobacco companies is wrong, then deception on the part of public health practitioners and policy makers is also wrong. In fact, I find it even more disturbing, because I view it as our ethical responsibility to be honest, forthright, and transparent in our communications with the public.

The Campaign for Tobacco-Free Kids and its coalition of health groups has every right to stand shoulder to shoulder with Philip Morris in helping the nation's largest tobacco company achieve its prized legislative goal. But they have no right to deceive the American public in order to promote that legislation.

I find the entire effort by the nation's major anti-smoking groups (led by the Campaign) to promote the FDA tobacco legislation to be one huge campaign of deception. When the two chief sponsors of the legislation cannot get in front of the American people without pulling the wool over our eyes, you know you've got problems.

I don't think it's possible for me to overstate the extent of my condemnation of the tactics of supporters of the proposed FDA tobacco legislation. Honestly, I don't see anything more ethical in their behavior than in the deceptive communications of the tobacco companies.

IN MY VIEW: FDA Tobacco Legislation Would Be Death Knell for Tobacco Harm Reduction

Perhaps the most compelling reason why I view the FDA tobacco legislation being introduced into Congress this week by Senator Edward Kennedy and Representative Henry Waxman as a measure that will harm, rather than protect, the public's health, is that the legislation would essentially put an end to a harm reduction approach in tobacco control. Yesterday, I offered my opinion that the proposed FDA tobacco legislation would put a death knell to harm reduction efforts. Today, I explain exactly why.

Please note that this analysis is based on the text of the legislation that was introduced into the previous two Congresses. To the best of our understanding, the legislation to be introduced in the coming days will be virtually identical to that legislation. Obviously, the analysis which follows depends on the accuracy of that assumption. But all indications are that the bills to be introduced by Senator Kennedy and Representative Waxman will be the same as the bills introduced the past two years.

The Rest of the Story

The critical flaw in the proposed legislation is section 911(g)(1). This is the Modified Risk Product section of the bill.

Based on my analysis, I have concluded that the Modified Risk Product section of the proposed FDA legislation would make it virtually impossible for modified risk products to enter the market, while at the same time, allowing reduced exposure products to essentially be falsely marketed as reduced risk products (thus institutionalizing the very problem that the health organizations have expressed so much concern about).

Here are the specific problems:

1. The legislation lists several criteria for achieving approval of a modified risk product. The most important are the following: "the Secretary shall approve an application for a modified risk tobacco product filed under this section only if the Secretary determines that the applicant has demonstrated that such product, as it is actually used by consumers, will--`(A) significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and `(B) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.

Section 911(g)(1)(A), the (A) clause above places an insurmountable obstacle in the path of approval of modified risk products. In order to demonstrate that the product, as actually used by consumers, will significantly reduce the risk of tobacco-related disease to individual users, large-scale, long-term epidemiologic studies are necessary. Even ignoring the requirement under 911(g)(1)(B), the (B) clause above (which itself appears to introduce an insurmountable obstacle), the bill as currently written precludes any harm reduction approach to tobacco control both by making it impossible for such products to meet the conditions for approval and by eliminating any incentive (especially economic) to develop such products. Thus, the bill may have the exact opposite effect that many believe it should have. It protects the existing high-risk products on the market.

It is critical for the public and policy makers to understand the ramifications of section 911(g)(1). In order to market a reduced risk product, a cigarette company would have to demonstrate that the product, as actually used by smokers, would substantially reduce the actual risk of disease among individual tobacco users.

There is only one way to do this. And that is to conduct a long-term epidemiologic study in which one compares the disease risk of the modified product with that of a comparison product over a long time period and among a large population of smokers.

There are all kinds of complications with conducting such a study. First, it would be tremendously expensive. Second, it would take, at a minimum, 10-20 years to follow the smokers long enough to monitor changes in disease. For cancer risks in particular, you would have to follow smokers for about 20 years before you would be able to draw definitive conclusions regarding any reductions in risk.

Third, there are all kinds of research complications that would make it difficult to draw accurate conclusions. The only way to credibly demonstrate a reduction in risk would be to conduct a randomized clinical trial, where smokers were randomized to either smoke conventional cigarettes or the putative reduced risk cigarettes. But conducting a randomized trial of smoking would be unethical; such a study is impossible.

The best that could be hoped for is a natural experiment type of study in which a product is "test-marketed" and that population of smokers (i.e., guinea pigs) are monitored for 10-20 years. But this is a catch-22. How can you test-market the product if you need to obtain FDA approval before you can test-market it? The only way you could do this would be to market the product as a conventional cigarette (not let anyone know that it is a potentially reduced risk product). But to do that, you would destroy the study, because it is your obligation to demonstrate that as actually used by consumers, the product would reduce risk. Smokers might use the product very differently if they believe it is a reduced risk product than if they don't.

In other words, the legislation does not merely make it difficult to market a reduced risk product. It makes it literally impossible.

2. The bill contains a special rule that would allow FDA to approve certain modified risk products that cannot meet the criteria listed under (A) and (B) above. Such products must only claim to be reducing exposure to, or reducing levels of or being free of a particular constituent. Specifically, such products can be approved if "scientific evidence is not available and, using the best available scientific methods, cannot be made available without conducting long-term epidemiological studies for an application to meet the standards set forth in paragraph (1)." In such cases, the major criterion that must be met is as follows: "the scientific evidence that is available without conducting long-term epidemiological studies demonstrates that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is anticipated in subsequent studies."

Thus, Section 901(g)(2)(A) essentially allows products that do not claim to reduce risk but merely claim to reduce exposure to or levels of a particular constituent to be approved by simply showing that a reduction in risk is ANTICIPATED in subsequent studies. This is a very weak standard. As long as there is any promising preliminary evidence, one could argue that reduced risk is expected if it were to be studied (this is a far cry from demonstrating reduced risk, especially given the many uncertainties including the actual use of the product by consumers and unintended side effects or consequences).

The effect of 901(g)(2)(A), then, is essentially to allow the approval of reduced exposure products and to allow these products to be marketed as such, even though there is shoddy scientific evidence of any health benefit. This institutionalizes the very problem (unsubstantiated health claims) that health groups supporting this legislation have expressed so much concern about. The fact that the bill does not allow these products to represent themselves as reducing health risk is largely irrelevant, because consumers are going to perceive them as reducing risk. How else would someone interpret a claim of reduced exposure?

Of note, the bill does require that there be testing of consumer perception which shows that as the product is proposed to be labeled and advertised, it will not mislead consumers into thinking that the product reduces health risk. However, there are no restrictions on who must do the consumer testing and what the conditions or protocols must be. It would be relatively easy for a company to do consumer testing in such a way that they obtain the result they want to show. Anyone familiar with survey research, focus group studies, or other types of formative research knows that the way questions are asked and the specific protocols used can shape consumer responses substantially. Similarly, post-market surveillance protocols are left to the companies.

The proposed FDA legislation is thus the worst of both worlds. On the one hand, it allows companies to gain a government sanction to market products under the guise of reduced risk by merely calling their product reduced exposure (does the term "lights" ring a bell?). On the other hand, it prevents companies from marketing products that may truly be reduced risk products by putting an impossible regulatory burden in the path of such products.

Despite all the rhetoric, the proposed FDA legislation would do nothing to save lives, but would instead ensure that the highest risk products remain firmly entrenched in the marketplace, without any competition from what could be life-saving alternatives. Of course, this lack of effective competition is why Philip Morris adores this legislation.

What it comes down to is protecting the profits of the nation's largest tobacco company at the expense of the public's health. That Philip Morris is lobbying for this legislation makes perfect sense, and it is the company's fiduciary responsibility to do nothing less. That the Campaign for Tobacco-Free Kids and other major anti-smoking groups are joining alongside Philip Morris in promoting this legislation is nothing less than a travesty.

Told You So: Flawed Tobacco Regulatory Scheme Supported by Major Anti-Smoking Groups Was Debunked Three Years Ago

In a very insightful commentary entitled "What's Fraud for Big Tobacco is Regulation for Big Government," Jacob Sullum over at Reason Magazine adds his own take on the new Tobacco Control article demonstrating that machine-measured cigarette emissions have little relation to actual human exposure and are therefore valueless consumer information. Like me, he sees the uncertainty of these numbers in predicting actual human health risks, and therefore, the senselessness of the Harvard nicotine yield report and the publicity that followed it, which bemoaned small increases in machine-measured nicotine yields over time. He also notes that the proposed FDA tobacco legislation would essentially charge the government with disseminating, in Big Tobacco's stead, potentially misleading information about cigarette emissions that could well deceive consumers. Finally, he agrees that the proposed legislation would serve as a death knell for potentially safer cigarettes by setting up an impossible regulatory hurdle for the approval of new, possibly reduced risk tobacco products.

What's most interesting is that Sullum actually came to this conclusion in a column back in September 2003 (which I wasn't aware of), in which he argued that the proposed FDA regulation could actually kill people, rather than save lives, by making it impossible to market what may be far less hazardous tobacco products: "Sen. Judd Gregg (R-N.H.) promises that his bill giving the Food and Drug Administration authority over tobacco products will "save lives." But it could kill people instead. That's because the bill, which the Senate Health Committee is expected to consider soon, authorizes the FDA to block the introduction of safer tobacco products. In deciding whether to allow a new product on the market, the agency is supposed to weigh "the risks and benefits to the population as a whole." And what the FDA thinks is good for "the population as a whole" is not necessarily what's good for individual consumers."

In that piece, Sullum also points out (as I have recently) that by giving FDA the authority to reduce nicotine levels in cigarettes, the legislation could also harm health: reduced nicotine would lead to increased compensatory smoking and higher tar delivery, increasing the carcinogenic effects and chronic lung impairment caused by cigarettes.

The Campaign for Tobacco-Free Kids and a long list of major anti-smoking organizations supporting the legislation just don't seem to get it. Let's hope, however, that our policy makers do. Well, we have one thing working in our favor. Many of those same anti-smoking groups have made such absurd statements in the past months, that maybe, just maybe, their credibility will not quite be so high this time around. Maybe we're asking just enough questions, and demanding just enough logic and reasoning, that these groups' deceptive propaganda will not carry the day.

IN MY VIEW: New Study Shows that FDA Tobacco Legislation Would Set Up System of Government-Sponsored Fraud

In her final opinion in the DOJ tobacco lawsuit against the tobacco companies, Judge Gladys Kessler ruled that the defendants had engaged in fraud by marketing cigarettes that rated lower yields via machine testing in a way that falsely led consumers to believe that these products offered a health benefit over higher machine-yield products.

A major part of the basis for this decision was a body of literature demonstrating that machine-yields of nicotine and other tobacco constituents have no direct relationship with actual human exposure, and thus with actual health risk, either on an individual or a population level. Machine yields, for example, do not adequately account for changes in human smoking behavior (e.g., compensation) which accompany any change in the yields of cigarettes.

A report released yesterday by the journal Tobacco Control and written by a group of tobacco control experts confirmed not only that machine-measured toxin yield information is virtually meaningless, but that newer advances in the way in which these yields are measured - which attempt to more closely simulate actual smoking behavior - are inadequate, and even these new methods do not yield information that is of any consumer value.

"Although each of the testing regimes will help to "characterise" how a product performs under a given set of smoking conditions, none of the smoking regimes "represent" human behaviour in terms of compensatory smoking and none is likely to produce emissions that will be markedly associated with human exposure or risk, either for individual smokers or for population-level differences between brands." ...

"After nearly 40 years—and after great cost to public health—the public health community is now coming around to the realisation that lower ISO emission cigarettes are not lower-risk products. Unfortunately, many regulators fail to understand the distinction between "product characterisation" and predicting human exposure. At the same time as they insist that cigarette emissions are not measures of risk, various regulators continue to use cigarette emissions in ways that assume a link between the machine emissions and human exposure. Many jurisdictions continue to require that quantitative levels of tar, nicotine and carbon monoxide appear on packages. These numbers continue to be misunderstood and misused by smokers, including smokers in the most affluent and highly educated countries in the world. To date, there is no evidence that quantitative emissions constitute effective consumer information, and several scientific bodies have rightly called for the removal of these emissions from packages. ... the tobacco industry should be prohibited from using machine emissions in any of its labelling, advertising or marketing directed at consumers, even if accompanied by "warnings" or disclaimers, such as those that currently appear in the US and Europe." ...

"patterns of use must be examined to understand the interaction between product design and smoking behaviour in humans, and to identify systematic differences across products. Products that deliver fewer toxins for a fixed volume of smoke and also promote greater smoke intake when used by consumers are not lower-risk products. Likewise, products that deliver higher amounts of toxins, but discourage repeated use might potentially be seen as harm reducing compared with conventional cigarettes."

At the same time as tobacco control experts were concluding that regulation of machine-measured cigarette constituent emissions was of no public health value and would actually be deceptive to the public, a prominent tobacco control group - the Campaign for Tobacco-Free Kids - was pushing for FDA legislation that would regulate cigarettes primarily by giving the FDA the authority to limit the machine-measured yields of certain of their constituents.

The Rest of the Story

This is the logic that underlies the thinking of the modern day tobacco control movement? Is this the best that we have to offer?

We know that measurements of the amounts of various constituents in cigarettes have no demonstrable relationship with actual human exposure or with actual human health risk, so we propose a system to regulate the safety of cigarettes that relies upon reducing the measured levels of various smoke constituents. What a brilliant idea!

We attack the tobacco companies for relying upon cigarette constituent measurements in making implied health claims, take them to court, get them convicted for fraud, and then proceed to go ahead and propose to set our own cigarette constituent level regulations, thereby making our own unsubstantiated implied health claims.

Unfortunately, the idea isn't just stupid. It's also damaging. The reason? Because like the machine-measured nicotine yields that we blasted the tobacco companies for relying upon in their communications, these FDA-sanctioned tobacco constituent levels will have no demonstrable relationship to the public's health, yet they will most certainly be interpreted by consumers as conveying an improved degree of safety.

There is no question that by virtue of cigarettes being placed under the regulatory jurisdiction of the FDA and by virtue of FDA promulgating "product safety standards," the public is going to assume that cigarettes have been made to be a safer product. However, those product safety standards are none other than specified reductions in a number of specifically chosen tobacco constituents, whose levels have not been shown to correlate directly with human health risk.

Essentially, what the proposed FDA legislation would do is simply change who is committing the fraud. Right now, it's the cigarette companies doing the dirty work, marketing reduced tar and reduced nicotine cigarettes in a way that deceives consumers into believing that these products are known to be safer. If the FDA legislation is enacted, then it will the government who is doing the dirty work, implying to the public that reduced X and Y cigarettes are known to be safer, when there is absolutely no evidence that such a product would, in fact, be safer.

No wonder why Philip Morris loves this legislation so much. It completely takes away the risk of litigation for fraud, yet allows the tobacco companies to tell consumers that they are complying with stringent product safety standards, assuring a safer product that is produced under the strict scrutiny of the Food and Drug Administration.

This whole thing is a huge hoax in the making.

It has the potential to institutionalize the fraud that the tobacco companies have committed, but to put it into the hands of our own government.

The Tobacco Control review article points out many reasons why regulation of tobacco smoke constituent levels would not necessarily produce a safer product: "not all constituents change to the same extent or even in the same direction under different testing regimes—for example, the NNK and benzo[a]pyrene:nicotine ratios decrease under more intense puffing conditions, whereas the nicotine ratio for carbon monoxide increases, as does the overall tar:nicotine ratio. It is unclear to what extent certain emissions can be reduced independently of others. Manufacturers have also shown their skill in substantially reducing machine emission levels through subtle design changes. Recent evidence from the UK suggests that tobacco manufacturers have adhered to the "10–1–10" limits on ISO emissions simply by increasing the level of filter ventilation so that brands provide deceptively low readings under machine conditions. Filter ventilation is the most prominent, but by no means the only design change available to manipulate yields. ... Emission limits will require considerable resources to implement and monitor, resources that may exceed the current capacity of regulators. There are also concerns that emission limits would exempt tobacco manufacturers from liability. Most important, it is uncertain how consumers will respond to emission regulation. Despite clear scientific statements to the contrary, consumers may interpret emission limits as an indication that cigarettes are less harmful—much in the same way that they have interpreted emission reductions in the past. In fact, future emission limits may be even more likely to undermine perceptions of risk than in the past: "new" emission reductions would be based on a "superior" machine method, would be more comprehensive in scope, and may have the formal endorsement of the [FDA]. ... one can also envision how manufacturers might shape consumer response through packaging and marketing. Overall, regulations that achieve modest reductions in smoke toxicity but result in fewer quitters or more initiators are not effective policy measures."

But the most important reason why the product safety standard approach taken in the proposed FDA legislation is a potential hoax is that there is simply no evidence that cigarettes can be made to be a safer product, in actual human practice, simply by mandating a reduction in levels of specified smoke constituents.

We simply do not know which constituents, at what levels, and in what combination, result in what degree of risk of what diseases that are caused by smoking.

Anyone who promises you that they are going to "save countless lives" via these product safety standards (precisely what the Campaign for Tobacco-Free Kids is telling its constituents) would probably also be effective in selling you a bridge in Brooklyn.

In one respect, the Campaign for Tobacco-Free Kids is precisely correct in stating that this legislation is going to save countless lives. It is so unclear that product safety standards will do anything to reduce overall health risks that it is impossible to count any lives that will be saved. Perhaps that's why the Campaign is having trouble counting them.

By the way, I'm not expecting that the Campaign or any other anti-smoking group would have all the answers to these issues. I don't expect them to be able to solve the problem. What is inexcusable, however, is pretending that they have a solution that is going to protect the public's health and save countless lives when in fact, we don't have a clue that we're going to be able to regulate the product in a way that makes it any safer.

Ultimately, there's only one way that I think even has the potential to be successful in developing safer cigarettes or other tobacco products. And that's to allow the free market system to work. Free market competition could, possibly, result in a race to see which company could come up with safer products. The proposed FDA legislation, however, destroys the possibility of this free market competition by making it impossible for any tobacco company to market a truly reduced risk product. I'll provide more details about this in a subsequent post, but for now, suffice it to say that the legislation would make it virtually impossible to market a reduced risk product. The scientific hurdle that the legislation sets up in the way of marketing a reduced risk product is, in my opinion, insurmountable.

What the bill does, on the other hand, is set up a competition to see who can market a reduced exposure product, which, just like reduced-nicotine or reduced-tar cigarettes, is likely to be just as effective in killing people, but which would most certainly be interpreted by the public as implying a reduced health risk.

Essentially, what the proposed legislation does is set up a system of government-administered public fraud in order to benefit the tobacco companies.

Ironically, but shamefully, if that happens, the groups that you'll have to thank the most are the major anti-smoking groups themselves. The Campaign for Tobacco-Free Kids and Friends are the ones who have joined Philip Morris in promoting the establishment of this system of government-sponsored fraud to once and for all get the tobacco companies off the hook.

Soon, it will be the government that is doing to smokers what the tobacco companies have been doing to them for so many years.

New Study Casts Doubt on Significance of Harvard Nicotine Yield Report and Wisdom of FDA Tobacco Legislation

A new study published in the current issue of Tobacco Control concludes that machine-measured yields of nicotine and toxins in cigarettes are virtually meaningless, having no association with actual human exposure on either an individual or a population basis.

In the study, researchers reviewed a number of technologies used to measure nicotine and toxin emissions from cigarettes. The purpose was to assess how well these machine smoking regimes: "1) Represent human smoking behaviour, 2) Reduce the potential for industry exploitation, particularly in the area of risk communication, and 3) Serve as suitable measures for product regulation."

In terms of the first goal, the researchers concluded that none of the machine measurement methods had any meaningful association with actual human exposure or risk of disease, either on an individual or a population level:

"Although each of the testing regimes will help to "characterise" how a product performs under a given set of smoking conditions, none of the smoking regimes "represent" human behaviour in terms of compensatory smoking and none is likely to produce emissions that will be markedly associated with human exposure or risk, either for individual smokers or for population-level differences between brands."

In terms of the second goal, the researchers concluded that the use of machine-measured nicotine or toxin yields leaves open the door to serious distortion of smoking risks in communications to the public:

"After nearly 40 years—and after great cost to public health—the public health community is now coming around to the realisation that lower ISO emission cigarettes are not lower-risk products. Unfortunately, many regulators fail to understand the distinction between "product characterisation" and predicting human exposure. At the same time as they insist that cigarette emissions are not measures of risk, various regulators continue to use cigarette emissions in ways that assume a link between the machine emissions and human exposure. Many jurisdictions continue to require that quantitative levels of tar, nicotine and carbon monoxide appear on packages. These numbers continue to be misunderstood and misused by smokers, including smokers in the most affluent and highly educated countries in the world. To date, there is no evidence that quantitative emissions constitute effective consumer information, and several scientific bodies have rightly called for the removal of these emissions from packages. ... the tobacco industry should be prohibited from using machine emissions in any of its labelling, advertising or marketing directed at consumers, even if accompanied by "warnings" or disclaimers, such as those that currently appear in the US and Europe."

In terms of the third goal, the researchers concluded that because of the general lack of a relationship between machine-measured emissions and actual exposure, and because of the fact that smokers will change their behavior in response to varying constituent yields, these emission measurements are not currently suitable as measures for product regulation:

"patterns of use must be examined to understand the interaction between product design and smoking behaviour in humans, and to identify systematic differences across products. Products that deliver fewer toxins for a fixed volume of smoke and also promote greater smoke intake when used by consumers are not lower-risk products. Likewise, products that deliver higher amounts of toxins, but discourage repeated use might potentially be seen as harm reducing compared with conventional cigarettes. Measures of realistic puffing behaviour and inhalation patterns are, therefore, important for understanding different chemical and biological profiles associated with products."

The researchers go so far as to conclude that because these machine-measured nicotine and toxin yields are so meaningless, they should be removed from all cigarette labeling and that communicating this information to the public is inherently misleading, deceptive, and likely to create an erroneous impression of the actual health risks of tobacco products, even if the statements are accompanied by disclaimers.

The Rest of the Story

If you're paying attention, and you think about it for a minute, you will realize that what this means (if the researchers' conclusions are valid), is that the Harvard nicotine yield report was essentially meaningless and that despite the report's disclaimer at the end, it was inherently misleading to the public about the public health risks associated with lower or higher nicotine products.

This new review article concludes that machine measured yields - including nicotine yields - have no meaningful association with actual human exposure, either in individuals or on a population level. It concludes that nicotine yield differences between brands are also meaningless in terms of actual exposure.

Well if that's true, then there is no significance to a report which concludes that machine-measured nicotine yields have increased slightly. It simply has no implications for drawing conclusions about either individual or population-based exposure in actuality.

The Harvard report did acknowledge this point, noting that "The increase in smoke nicotine yield does not necessarily signify any change in exposure within the population of smokers, particularly as human smoking behavior is compensatory and will adjust for differences in smoke yield."

However, as the Tobacco Control article points out, this disclaimer alone is not enough to prevent the public from being widely misled - as has happened.

This article also makes it clear that the FDA tobacco legislation, as currently proposed, will not only fail to protect the public's health, but will likely lead to government deception of the American consumer. The government, instead of tobacco companies, would (under the proposed legislation) control the machine-measured yields of various constituents, giving consumers the false impression that this regulation of machine-measured yields has any relationship whatsoever to human health.

In other words, what we as tobacco control practitioners have taken the tobacco companies to court over would now be something practiced by the U.S. government.

There are 2 very strange aspects to this story, which, for the life of me, I cannot figure out.

1. First, after concluding that machine-measured nicotine and toxin yields are essentially meaningless and have no relationship to actual exposure or actual health risk on an individual or population level, and after concluding that this information has no consumer value and should be taken off cigarette labeling, the authors of this paper conclude: "We strongly endorse the need to make information on cigarette emissions public to advance the evidence base for effective product regulation."

That makes no sense whatsoever. They just got through describing in detail why this information is meaningless, and they went so far as saying that the information must be taken off labeling so as not to mislead anyone. They also just got through saying that merely by providing this information, the tobacco companies are committing fraud and deceiving consumers about the true risks of their products. So how do you get from there to a conclusion that there is a "need" to make this information available to the public?

2. Second, in the Harvard nicotine yield report itself, after noting that "the increase in smoke nicotine yield does not necessarily signify any change in exposure within the population of smokers, particularly as human smoking behavior is compensatory and will adjust for differences in smoke yield," why do the authors nevertheless go ahead and draw their conclusions as if the increase in nicotine yields does necessarily signify a change in exposure within the population of smokers?

I seem to really be missing something here. Maybe it's just advancing age, but the logic of the policy analysis that is going on in tobacco control right now is evading me completely.

Senator Kennedy Joins Campaign for Tobacco-Free Kids in Pulling Wool Over Eyes of American People; Integrity Impossible to Find

On January 17, Senator Edward Kennedy released a statement in response to a Harvard University School of Public Health report which concluded that nicotine yields of cigarettes have increased steadily over the past eight years. In the statement, Senator Kennedy condemned Big Tobacco for addicting millions of young smokers due to these rising nicotine levels and called it a travesty for Congress to be an accomplice to this addiction by failing to enact legislation that would allow the Food and Drug Administration (FDA) to prevent this from happening.

Senator Kennedy said: “This study is an extraordinary public service by Harvard’s School of Public Health. It’s dramatic new proof that Big Tobacco is addicted to addicting millions of young smokers into lifetimes of illness and early death. Congress has been an accomplice in the travesty because of the success of the tobacco lobby in blocking real reform. Hopefully, the study will be a wake-up call to persuade Republicans and Democrats alike to enact long overdue legislation allowing the FDA to regulate cigarettes and deal with their enormous risks.”

A day later, the Campaign for Tobacco-Free Kids issued a press release in which they argued that the increasing nicotine levels signaled the need for legislation that would grant the FDA the authority to reduce nicotine levels in order to protect the public's health by preventing companies from addicting children with their nicotine.

The Campaign stated: "A new study released today by the Harvard School of Public Health shows the critical need for Congress to enact legislation granting the U.S. Food and Drug Administration (FDA) authority over tobacco products. The Harvard study expands on and confirms an August 2006 study released by the Massachusetts Department of Public Health that found that tobacco companies have deliberately increased the levels of nicotine in cigarette smoke since 1998. The FDA legislation would require tobacco companies to disclose to the FDA changes in their products and provide FDA the authority to require them to reduce levels of constituents, like nicotine that make them more harmful or more addictive. ... These studies demonstrate that what the tobacco industry knows and what consumers don’t, can kill us. ... Legislation to allow the FDA to regulate tobacco should be given a high priority and scheduled for action early this year. The proposed legislation would grant the FDA the authority and resources to stop harmful tobacco company practices that continue to addict children, mislead consumers and devastate the nation's health."

The Rest of the Story

Today, I am revealing my opinion that Senator Kennedy's and the Campaign for Tobacco-Free Kids' statements were little other than public relations and propaganda ploys, which greatly deceive the American public into believing that the legislation which Senator Kennedy is introducing and that the Campaign for Tobacco-Free Kids is supporting would actually do something to protect our nation's youths from the addictive nature of nicotine in cigarettes.

It turns out that the addiction of millions of our nation's kids by nicotine in cigarettes is apparently not such a travesty, as Senator Kennedy and the Campaign would have us believe. Nor would the legislation that they are proposing do anything to address the problem of nicotine addiction of our nation's children.

In contrast, Senator Kennedy and the Campaign are supporting legislation that would actually institutionalize the addiction of our nation's children into law, ensuring that the Food and Drug Administration could never address the problem of nicotine addiction of our children by requiring the elimination of nicotine from cigarettes. The legislation would ensure that cigarettes always contain nicotine, and thus always maintain the potential to addict our children, regardless of whether we ever reach a point where social norms change in a way that would otherwise make feasible the FDA's gradual phasing out of nicotine from cigarettes.

According to information released by Bill Godshall, Executive Director of Smokefree Pennsylvania, Philip Morris has issued a statement confirming that the legislation to be introduced this week by Senator Kennedy would indeed preclude the FDA from eliminating the nicotine in cigarettes.

According to the tobacco company's summary of the bill to be introduced: "The product standard section explicitly provides that only Congress could ... require 'the reduction of nicotine yields of a tobacco product to zero'. ... In addition, a performance standard may not have the effect of ... reducing nicotine yields 'to zero.'"

In other words, Senator Kennedy and the Campaign for Tobacco-Free Kids were full of crap.

They told the American people one thing, but did exactly the opposite.

They deceived the American people in their public statements, which turned out to be little more than public relations propaganda to make them sound concerned about the rising nicotine levels that apparently are addicting our children.

But when it really came down to it, they were not only not willing to do anything about that problem, but they did the opposite of what needed to be done. They permanently institutionalized nicotine addiction of our nation's children into the statutes of the United States (or at least they are trying to do so - not so fast, people like me and Bill Godshall aren't going to let them get away with this quite so easily).

Now before I get criticized for calling on the elimination of nicotine from cigarettes, let me make it clear that what I view as crap is not the idea that right now, it would not be feasible for the FDA to eliminate nicotine from cigarettes and therefore that it makes sense to preclude FDA from doing just that.

That's just an opinion about an appropriate strategy for dealing with the nicotine problem, and Senator Kennedy and the Campaign are certainly welcome to their opinions. I happen to think that it is not feasible at the present time and it would not be advantageous to eliminate nicotine from cigarettes at the present time. However, my personal opinion is that it doesn't make sense to tie the FDA's hands and place decisions about this issue into the realm of politics rather than science and public policy. I think one could easily avoid the problem by simply requiring the FDA to make a determination that its regulations are feasible and to consider the potential for social disruption, black markets, etc. in promulgating any regulation that would eliminate or phase out nicotine. Thus, FDA would have the authority to take such an action if it ever made sense, but would not be required to take the action.

What is crap, however, is telling the American public that the addiction of America's children by increasing nicotine levels is a travesty that we are going to address through FDA legislation and then to go back on one's word by not addressing that problem in the legislation, but rather, doing the opposite and making sure that the specific problem you stated was the need for the legislation will be codified into the laws of the United States.

That's about as low a level of integrity that I can imagine. It's worse than simply misleading the American public by making them think you're going to do something and then not doing it. It's worse, because you are actually making the public think you're going to do something and then doing the exact opposite.

And to make matters worse, not only are you doing the opposite, but you are ensuring that the original action you said you would take can never be done.

For Congress to amend the tobacco legislation once it is enacted is almost unfathomable. Congress only enacts tobacco legislation to begin with every 30 years or so. Once this law is enacted, you can put a fork in it - we're not going to see a revision of the legislation any time soon.

It's not like I didn't make an effort to warn Senator Kennedy and the Campaign about this. In addition to contacting both of them, my op-ed published last Sunday in the New York Times exposed the problem, and made it clear that merely reducing nicotine levels would not solve the problem. It would not eliminate the addictive potential of cigarettes and in fact, it would make cigarettes potentially far more harmful: smokers compensate to make up for reduced nicotine delivery; the increased tar delivery would increase rates of cancer and chronic lung disease.

Ironically, if you want to give the FDA the power to possibly reduce the harms of cigarettes, the one thing that might actually work would be to mandate very high levels of nicotine in cigarettes.

This would have two beneficial effects: first, it would substantially reduce the intensity of smoking and levels of consumption, reducing tar delivery and lowering cancer and chronic lung disease risks.

Second, it would make cigarettes all but "unpalatable" for kids, ensuring that fewer young people would take up the habit and have it turn into an addiction. But established smokers would still be able to obtain their nicotine.

It is not actually clear yet whether the bill to be introduced by Senator Kennedy would even allow the FDA to mandate increases in nicotine levels in cigarettes. But if the legislation is similar to that introduced in the past two sessions of Congress, I do not believe it would allow this approach.

According to section 907(a)(4)(a)(i) of that legislation, the FDA could only require reductions of certain constituents in cigarettes.

In fact, in my suggested revisions to the legislation which I sent to Senator Kennedy's office, I pointed out this problem. Specifically, I suggested the following revision:

"Section 907(a)(4)(a)(i) - Tobacco Product Standards: Tobacco Product Standards: Change the word 'reduction' to 'regulation.' This would allow FDA to regulate the overall cigarette design in terms of nicotine/tar ratios, rather than just reduce the nicotine, which would lead to compensatory increases in cigarette consumption. For example, a high nicotine/low tar cigarette could provide substantially reduced risk, as cigarette consumption might fall somewhat in combination with a reduction in carcinogen intake."

It's not clear to me exactly what the most reasonable and advantageous regulatory approach would be to reduce the harms of tobacco-related disease. And I would not be criticizing Senator Kennedy so harshly had he simply introduced the bill as it is. I am not criticizing him for failing to mandate the removal of nicotine from cigarettes or even for failing to grant the authority to FDA to do this. I am criticizing him for saying one thing and doing the opposite.

While I don't necessarily call for the removal of nicotine from cigarettes, I also don't put out press releases stating what a travesty it is that Big Tobacco is increasing their nicotine levels, showing how this demonstrates a need for FDA regulation, and promising to introduce or support legislation to address this problem, and then go out and make sure, behind the public's back, that the legislation contains language that precludes the FDA from addressing the problem.

It's quite interesting that Philip Morris apparently had detailed knowledge of the provisions of the bill before any of us in the public. Philip Morris was at the negotiating table that produced this deal in the first place a couple of years ago. And apparently, their support of the legislation (i.e., assured financial stability and increased market share) is far more important to those supporting it than the integrity and honesty in public statements and the actual health protection of the public.

In summary, what's very clear to me is that those who are pretending to take the responsibility for the public's health onto their shoulders and protect us from the hazards of cigarettes do not have a clue about the real scientific and public policy issues involved with the regulation of cigarettes - something I have personally been studying for the past 21 years and think I have a little bit of expertise in.

Not only that, but in pretending to be protecting us from the travesty of the addiction of our nation's children with the use of nicotine in cigarette products, Senator Kennedy and the Campaign for Tobacco-Free Kids are pulling the wool over the eyes of the public. They are saying one thing, and doing precisely the opposite.

That's not public health protection. It's not clarity and transparency and full honesty and disclosure. But most importantly, it's not the kind of integrity that I think we deserve from our public health organizations and our policy makers - especially when those organizations and policy makers take it upon themselves to tell us that they have the very solution to the problem they are bemoaning.

When it turns out their purported solution would actually institutionalize the very problem at hand, I think it's time to do more than simply ask questions.

Campaign for Tobacco-Free Kids' Campaign of Deception on FDA Legislation is Working; Public Has No Clue About Nicotine Policy Considerations

In the past weeks, I revealed a campaign being waged by anti-smoking groups - chiefly by the Campaign for Tobacco-Free Kids - to use data showing an increase in machine-derived nicotine yields in cigarettes over the past 8 years to indicate that tobacco companies are secretly and deliberately addicting youths with the nicotine they add to their products, that legislation is needed to address this problem, and that the FDA tobacco legislation to be introduced this week by Senator Edward Kennedy will do just that.

Here is what the Campaign for Tobacco-Free Kids said in its press release following the release of the Harvard report:

"A new study released today by the Harvard School of Public Health shows the critical need for Congress to enact legislation granting the U.S. Food and Drug Administration (FDA) authority over tobacco products. The Harvard study expands on and confirms an August 2006 study released by the Massachusetts Department of Public Health that found that tobacco companies have deliberately increased the levels of nicotine in cigarette smoke since 1998. The FDA legislation would require tobacco companies to disclose to the FDA changes in their products and provide FDA the authority to require them to reduce levels of constituents, like nicotine that make them more harmful or more addictive."

"Manufacturers of food, drugs and even pet foods are required to disclose to the FDA and the public changes in their products in order to protect the public health. Only the tobacco industry is exempt from these basic public health protections. These studies demonstrate that what the tobacco industry knows and what consumers don’t, can kill us."

"These studies add to the growing evidence that as smoking rates continue to decline, and more smokers try to quit, tobacco companies are actively trying to maintain addiction among smokers and addict a new generation of replacement smokers. The fact that the tobacco companies have been able to secretly increase nicotine levels in tobacco smoke occurred only because no federal or state agency currently has regulatory authority over cigarettes or what tobacco companies put in cigarettes. Legislation to allow the FDA to regulate tobacco should be given a high priority and scheduled for action early this year. The proposed legislation would grant the FDA the authority and resources to stop harmful tobacco company practices that continue to addict children, mislead consumers and devastate the nation's health."

OK. It sounds to me like what the Campaign for Tobacco-Free Kids is saying is that the increasing nicotine levels in cigarettes is a major public health problem that is endangering the public's health by making cigarettes more addictive and more harmful: "The FDA legislation would require tobacco companies to disclose to the FDA changes in their products and provide FDA the authority to require them to reduce levels of constituents, like nicotine that make them more harmful or more addictive."

Further, it sounds like what the Campaign for Tobacco-Free Kids is saying is that the addiction of our nation's children due to the levels of nicotine in cigarettes is a major problem, we have to do something about it, and the proposed FDA legislation would allow the FDA to take care of the problem.

There are two major problems with this kind of propaganda. First, it is deceptive with respect to the public health consequences of increased nicotine yields. In contrast to what the Campaign for Tobacco-Free Kids suggests, increasing nicotine levels do not make cigarettes more harmful, and there is little evidence that they make cigarettes more addictive. It is well-known that as nicotine yields increase, smokers smoke less and tar delivery is reduced. Increasing nicotine yields may actually have marginally positive public health benefits.

The Campaign knows very well that this is the case. In its post-trial brief in the DOJ tobacco case, the Campaign for Tobacco-Free Kids itself argued that: "the Record also demonstrates that these descriptors [e.g., "lights" and "low-nicotine"] were fraudulent. As the evidence adduced at trial overwhelmingly shows, the defendants knew and intended that “brand descriptors communicate a less hazardous cigarette than full-flavor brands,” ... the “data that have been used to justify the campaign for low nicotine cigarettes does nothing of the sort”. Therefore, tragically, smokers who switched to light and low tar mistakenly believed that doing so resulted in a real risk reduction of adverse health effects, when in fact, the perceived risk reduction was an “illusion.”"

So it seems pretty clear that the Campaign is well aware that nicotine yields in cigarettes do not correspond to the level of health hazard associated with smoking these cigarettes. In fact, the Campaign has gone so far as to argue that making any such public suggestion constitutes fraud - a criminal act if you are a tobacco company (but apparently acceptable if you are an anti-smoking group).

The second problem with this type of propaganda is that it deceives the public about the actual nature of the legislation that is being introduced this week. As a reader of this public statement, I would naturally assume that the FDA was going to be given the authority to regulate nicotine levels in cigarettes as appropriate to protect the public's health, to prevent the tobacco companies from "actively trying to maintain addiction among smokers and addict a new generation of replacement smokers," and to stop "harmful tobacco company practices that continue to addict children."

What is the most harmful tobacco company practice that continues to addict children? Without question, it's putting nicotine in the cigarettes. It's not increasing the levels. Even if levels stayed exactly where they are, cigarettes would remain a highly addictive product and would continue to addict our nation's children.

The truth, however, is that the proposed FDA legislation (according to a reliable source - Philip Morris), specifically precludes the FDA from removing the nicotine from cigarettes.

In fact, while I have yet to examine the actual legislation, it is possible that the bills actually preclude FDA from requiring an increase in nicotine levels - the only action FDA could take other than removing the nicotine that would actually improve the public's health.

Merely lowering nicotine levels - which the FDA legislation apparently intends the FDA to do - would be a public health disaster. Smokers would smoke more to obtain the same dose of nicotine, tar delivery would increase, and cancer and chronic lung disease rates would rise.

And this is what the Campaign had in mind when it told the public that the Harvard report shows the need for FDA regulation of nicotine levels? In my view, that's shameful.

The Harvard researchers themselves also seemed to be unclear at best as to the need for legislation that would give FDA the authority to regulate nicotine and why such legislation would benefit the public's health.

One co-author stated: "Policy actions today requiring the tobacco industry to disclose critical information about nicotine and product design could protect the next generation from the tragedy of addiction."

How in the world could merely disclosing the nicotine levels protect the next generation from the tragedy of addiction? Disclosing the levels - which, incidentally, are already disclosed to the Massachusetts Department of Public Health and publicly available on at least Philip Morris' website, would do nothing to prevent addiction. The only thing that would protect the next generation from the tragedy of addiction is to eliminate the nicotine. It's that simple.

I'm not calling for the elimination of nicotine, but I am suggesting that it is deceptive to suggest to the public that the solution to the problem of the "tragedy" of addiction is to require disclosure of nicotine levels. But that's about all that the FDA tobacco legislation to be introduced this week would do in terms of nicotine regulation. Unless you include requiring reductions in nicotine levels - which would be a public health disaster.

The Rest of the Story

Unfortunately, the deception about this issue from the Campaign for Tobacco-Free Kids and others has been effective in clouding the public's appreciation of the real public policy considerations involved in questions regarding the regulation of nicotine in cigarettes.

For example, an editorial published yesterday in the Online Ledger (Lakeland, Florida) argued that the Harvard report shows that legislation is needed to require companies to disclose nicotine yields to the FDA and to prohibit these companies from increasing nicotine content of their cigarettes: "Because tobacco is, essentially, an addictive drug, anti-smoking advocates have long argued that it should be regulated by the U.S. Food and Drug Administration. Presumably, FDA regulations could require companies to more precisely identify nicotine levels in their products and forbid them from steadily increasing nicotine content for the express purpose of addicting even more customers. The Senate passed such a bill in 2004, but it failed in the House. Perhaps now that Congress is under new leadership, the results of the Harvard study will provide fresh impetus for FDA regulation of what is, after all, a deadly substance."

Unfortunately, disclosure of the nicotine yields does nothing to protect anyone and forbidding companies from increasing nicotine is the last thing we would want to do. Higher nicotine to tar ratios would potentially yield a safer cigarette.

It does appear that the misleading statements by anti-smoking groups regarding the public health significance of the nicotine yields of cigarettes have resulted in a general misunderstanding among the public and the media about the real policy considerations regarding the issue of nicotine regulation.

What's so amazing to me is the way that anti-smoking groups appear to be able to twist and use information in completely opposite ways depending on their purpose. When they were trying to accuse the tobacco companies of fraud, they argued that nicotine yields are meaningless from a public health standpoint and lower nicotine does not necessarily mean a safer or less addictive cigarette.

But now that cigarette companies are increasing the nicotine levels, we seem to have forgotten all that and now all of the sudden it is a terrible public health detriment to have cigarettes with higher nicotine yields.

You can't have it both ways. Which is it?

The answer appears to be whatever way will achieve the best support for the pre-ordained agenda of the major anti-smoking groups.

A Must Read for Anti-Smoking Groups: U.S. News & World Report Article on Car Smoking Bans

An article by Dr. Bernadine Healy - a physician - in the Feb. 12 issue of U.S. News & World Report argues that despite the health risks of secondhand smoke for exposed children, banning smoking in cars is not justified.

Dr. Healy, who acknowledges the potential dangers of secondhand smoke for children, argues that banning smoking in cars in not justified for three main reasons:

1. It goes too far in "policing behavior and trouncing privacy." It opens the door to a slippery slope that includes other intervention such as regulating what foods parents can serve their kids and how much sun they can allow them to get.
2. It singles out a group which is disproportionately poorer and female (since moms are more likely to be ferrying their kids around places).
3. It uses a punitive approach, which may not only be less effective than education, but may be much worse. Parents may just decide to smoke in the safe confines of their own home, where exposure of their kids to secondhand smoke is much more serious, as it takes place for many hours (rather than just for minutes in a car).

This is a particularly eloquent, well-reasoned, and compelling commentary. It is indeed a must-read for all anti-smoking groups and advocates working on this issue. (And now I'm not the only physician who has spoken out publicly in opposition to such policies.)

Wall Street Journal Article Highlights Financial Conflicts of Interest of Chair of Federal Smoking Cessation Guidelines Panel

Two weeks after I revealed the extensive pharmaceutical company financial conflicts of interest among the chair and other scientists on panels that promulgated federal recommendations on treatment for smoking cessation and national smoking cessation policy (post 1; post 2), the Wall Street Journal today features an article that exposes and discusses these conflicts.

In an article entitled "Nicotine Fix: Behind Antismoking Policy, Influence of Drug Industry; Government Guidelines Don't Push Cold Turkey; Advisers' Company Ties," Kevin Helliker reveals the extensive pharmaceutical company financial conflicts of interest of Dr. Michael Fiore, chair of the national panel that developed guidelines for smoking cessation treatment as well as the panel that produced a national smoking cessation action plan that played a key role in the government's proposed remedies in the DOJ tobacco case.

According to the article, Dr. Fiore "holds a chair at Wisconsin that is funded by GlaxoSmithKline. He directs a tobacco research center that received nearly $1 million in funding from makers of quit-smoking medicine in 2004 and $400,000 in 2005. Between 1999 and 2004, Dr. Fiore personally pocketed $10,000 to $40,000 a year from the quitting-aid industry for honorariums and consulting work. He says he stopped such work in 2005."

Apparently, Dr. Fiore denied to Helliker that he has a conflict of interest. Helliker wrote: "Michael Fiore is in charge of revising federal guidelines on how to get smokers to quit. He also runs an academic research center funded in part by drug companies that make quit-smoking aids, and he personally has received tens of thousands of dollars in speaking and consulting fees from those companies. Conflict of interest? No, says Dr. Fiore, who has consistently declared that doctors ought to use stop-smoking medicine. He says his opinion -- reflected in current federal guidelines -- is based on scientific evidence from hundreds of studies."

The article reveals that the panels chaired by Fiore failed to give appropriate weight to the use of the cold turkey method of cessation, which population studies confirm to be the most effective, and instead, focused almost exclusively on the use of pharmaceutical aids.

A new panel is currently revising the smoking cessation guidelines, and the chair of that panel is none other than Dr. Fiore (plus, 7 of the panel's members have pharmaceutical company financial conflicts of interest). Despite the conflicts of interest, Fiore apparently denied that the pharmaceutical ties of himself and a number of other panel members represent a source of bias: "Dr. Fiore says his panel will give a fair hearing to all points of view on smoking cessation. He says the process is sufficiently collaborative to prevent bias, his or anyone else's, from creeping into the final product. He notes that many of the studies questioning the effectiveness of stop-smoking medication arose after the publication of the 2000 guidelines. The panel will scrutinize them closely before reaching any conclusions, he says."

Not so, said David Blumenthal, director of the Institute for Health Policy at Massachusetts General Hospital, who criticized the choice of Fiore as panel chair: "'The chairman of the committee should be unquestionably impartial,' says Dr. Blumenthal, who has published extensively on conflicts of interest."

The article also revealed that in at least two cases, Dr. Fiore's conflicts of interest were not disclosed in journal articles he wrote about smoking cessation methods and that Fiore admitted that the lack of disclosure may have been his fault: "In at least two medical-journal articles that Dr. Fiore wrote or co-wrote promoting the use of stop-smoking medicine, no mention was made of his financial ties to the makers of those treatments. Dr. Fiore says the editors of those journals may have ignored his disclosure or he may have failed to provide it."

The article also reveals an undisclosed conflict of interest of another smoking cessation researcher - Dr. Jack Henningfield - who, according to the article, "is a principal of Pinney Associates, a consulting firm whose largest client is GlaxoSmithKline, operator of the quit.com site. Other articles citing Dr. Henningfield's views on smoking have identified him as a professor at Johns Hopkins School of Medicine without mentioning the GlaxoSmithKline connection. ... Dr. Henningfield says he always tells journalists about his financial ties to industry. But in an interview with The Wall Street Journal last summer, Dr. Henningfield promoted the use of stop-smoking medicine without volunteering any information about those ties."

The article cites a number of independent (non-pharmaceutical company funded) scientific experts who believe that the near-exclusive focus on pharmaceutical methods for smoking cessation is undermining smoking cessation efforts by discouraging potential quitters who don't want to treat nicotine addiction with more nicotine.

The Rest of the Story

There is nothing ethically wrong with having a conflict of interest. Many researchers do. However, there is something wrong with failing to acknowledge or disclose that conflict of interest. I don't know exactly what Dr. Fiore told the reporter, but it is quite clear that the reporter got the impression that Fiore does not see any conflict of interest in his participation on the national smoking cessation guideline panel and does not see any potential for this conflict to create bias in the panel's deliberations.

That, and not the conflict itself, is what the rest of the story is all about. That, and not the conflict, is what represents a deterioration of the scientific integrity in a major segment of the tobacco control movement.

How can someone possibly deny that having a pharmaceutical company endowed chair and receiving $1.4 million from manufacturers of smoking cessation drugs in 2004 and 2005 represents a conflict of interest in chairing a national panel that is supposed to make unbiased recommendations about the appropriate course of treatment to recommend for smokers who wish to quit throughout the nation?

How can someone who has a million dollar plus conflict of interest deny that this conflict represents a source of bias when it comes to making those recommendations?

How could someone with a million dollar plus conflict of interest fail to make sure that the conflict was disclosed in two prominent journal articles?

Let me make one thing clear. There is no question that a conflict of interest exists.

The question is not whether a conflict exists, it is whether that conflict should disqualify a person from participating on, or chairing a panel that is supposed to make recommendations for the nation regarding a smoking cessation treatment strategy.

Given the fact that Dr. Fiore is defending the conflict, apparently denying that there is a conflict to the reporter, and denying that it will introduce bias, I don't think there is any doubt that the conflict is one that cannot and should not be tolerated. I agree with Dr. Blumenthal that the chair of the panel should be unquestionably impartial.

It's not like we don't have enough problems with scientific integrity without this scandal. Regular readers of this blog know that there are serious problems of scientific accuracy, integrity, and ethical conduct going on regarding the communication of information to the public. It's not like we need this on top of all that.

I stand by my earlier warning that we do face a crisis of scientific integrity in the tobacco control movement. Perhaps tobacco control practitioners can ignore these premonitions when they only appear in a blog. But when you start reading about these scientific scandals in the Wall Street Journal, then I think it's time to take notice.

Question of the Day: Why Did Anti-Smoking Groups Choose Not to Qualify their Sudden Death Claims?

Yesterday, I discussed what I consider to be the most misleading health claim being made by anti-smoking groups regarding the acute cardiovascular effects of secondhand smoke: the claim that 2 hours of exposure increases a nonsmoker's risk of sudden death from a fatal cardiac arrhythmia.

Groups like TobaccoScam and the American Heart Association have outlined a number of acute effects of brief secondhand smoke exposure. According to these groups:

1. 20 minutes of exposure to secondhand smoke increases the risk of a heart attack by activating platelets;
2. 30 minutes of exposure to secondhand smoke causes stiffened arteries that increase risk of heart attack; and
3. 2 hours of exposure puts nonsmokers at risk of sudden death due to fatal cardiac arrhythmias.

According to both of these groups: "All of these effects not only increase the long term risks of developing heart disease, but also increase the immediate risk of heart attack."

Thus, these communications imply that if you are a nonsmoker and are exposed to secondhand smoke for between 20 minutes and 2 hours, you are at increased risk of a heart attack and/or of sudden death.

There is no truth to these claims as they apply to a person without severe heart disease. However, there is some truth to the notion that a nonsmoker who has severe, pre-existing coronary artery disease could potentially be at risk of having a coronary event (i.e., a heart attack or arrhythmia) triggered by exposure to secondhand smoke, because of tobacco smoke's observed effects on platelet activation, endothelial dysfunction, artery elasticity, and cardiac autonomic function.

These anti-smoking groups, as well as nearly 100 more which have made similar claims, had a choice to make in presenting this "scientific" information.

OPTION A: The first option was to present this information as applying to anyone exposed to secondhand smoke. Presenting the information in this way would lead anyone to believe that they are personally at risk of a heart attack or sudden death from a short secondhand smoke exposure. This option would imply that even a healthy nonsmoker could suffer a heart attack or die suddenly due to a brief exposure. This option, therefore, would represent a very deceptive and misleading depiction of the scientific evidence.

OPTION B: The second option was to qualify the communications to make it clear that any risk of an acute coronary event applies only to individuals with pre-existing, severe coronary artery disease (who are basically heart attacks waiting to happen and for whom a number of exposures that affect endothelial function and platelet activity - such as eating a high-fat meal - could also potentially trigger a coronary event). Presenting the information in this way would have made it very clear to the public that an otherwise healthy nonsmoker is at no risk of dropping dead of a heart attack or a fatal cardiac arrhythmia due to a brief secondhand smoke exposure. This option would represent a reasonably accurate depiction of the scientific evidence.

Clearly, option A would present the information in a way that, although very misleading, would scare the public and sensationalize the severity of the acute effects of even a brief secondhand smoke exposure.

Option B would present the information in a reasonably accurate way, but would not have the kind of sensational and emotional impact as option A.

The Rest of the Story

The rest of the story is that faced with this option, nearly 100 anti-smoking groups have chosen option A.

To me, this is what, above and beyond the misleading claims themselves, signals a crisis of credibility and integrity in the tobacco control movement.

Why?

Because the fact that the groups had a choice, but decided to go with the option that sacrificed accuracy and clarity for emotional impact, suggests that the decision to mislead the public was an intentional one, not an accident.

Assuming that the anti-smoking groups know what they are talking about (and if they do not, then I think it is highly irresponsible of them to be communicating important health information like this to the public), these groups had the option of presenting the information accurately, or presenting it in a misleading way. Nearly 100 of these groups have chosen to present the information in a misleading and deceptive way. I can only conclude that this decision was intentional, since it must have occurred to these groups that both options were available.

Essentially, it appears that what anti-smoking groups are doing is exactly what we constantly accuse the tobacco companies of doing: distorting the science just enough so that their communications grossly mislead people, but fall just short of representing blatant or outright lies.

Leaving out the important fact that a brief secondhand smoke exposure poses no acute cardiovascular risk to a healthy nonsmoker is a sly tactic that completely distorts the communication to the public in a way that grossly misrepresents the science and deceives and misleads people, but falls short of constituting an outright lie because there is a specific context in which the statement has some degree of potential correctness.

But as public health practitioners, I find it unethical for us to be using sly tactics that distort the science in order to grossly misrepresent the scientific evidence and deceive and mislead people, even if we cannot be properly accused of lying.

This is precisely what we are doing - and we should be ashamed of it. It is unbefitting of public health organizations. It is irresponsible. And most importantly, it is unethical.